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ACTIVE NOT RECRUITING
NCT04041050
PHASE1

A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib.

Official title: A Phase 1 Open-Label Study Evaluating the Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Myeloproliferative Neoplasm Subjects

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2019-11-08

Completion Date

2026-12-31

Last Updated

2025-02-14

Healthy Volunteers

No

Interventions

DRUG

Navitoclax

Tablet; Oral

DRUG

Ruxolitinib

Tablet; Oral

DRUG

Celecoxib

Capsule; Oral

Locations (42)

City of Hope /ID# 239769

Duarte, California, United States

Providence - St. Jude Medical Center /ID# 242558

Fullerton, California, United States

Moores Cancer Center at UC San Diego /ID# 229584

La Jolla, California, United States

UCLA /Id# 222784

Los Angeles, California, United States

Northwestern University Feinberg School of Medicine /ID# 224203

Chicago, Illinois, United States

Norton Cancer Institute - St. Matthews /ID# 239300

Louisville, Kentucky, United States

Duplicate_Brigitte Harris Cancer Pavilion /ID# 238686

Detroit, Michigan, United States

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 242554

Omaha, Nebraska, United States

Duplicate_East Carolina University Brody School of Medicine /ID# 238560

Greenville, North Carolina, United States

Gabrail Cancer Center Research /ID# 228924

Canton, Ohio, United States

Pennsylvania Cancer Specialists Research Institute - Gettysburg /ID# 242550

Gettysburg, Pennsylvania, United States

Virginia Commonwealth University Medical Center Main Hospital /ID# 228169

Richmond, Virginia, United States

Cliniques Universitaires UCL Saint-Luc /ID# 225314

Woluwe-Saint-Lambert, Brussels Capital, Belgium

UMHAT Sveti Georgi /ID# 240022

Plovdiv, Bulgaria

UMHAT Sveti Ivan Rilski /ID# 240077

Sofia, Bulgaria

Klinicki bolnicki centar Zagreb /ID# 240140

Zagreb, City of Zagreb, Croatia

Centre Antoine Lacassagne - Nice /ID# 242293

Nice, Alpes-Maritimes, France

CHU Amiens-Picardie Site Sud /ID# 240792

Amiens, Somme, France

AP-HP - Hopital Saint-Louis /ID# 240685

Paris, France

IUCT Oncopole /ID# 242353

Toulouse, France

Universitaetsklinikum Freiburg /ID# 222791

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Klinikum Kassel /ID# 225440

Kassel, Hesse, Germany

Universitaetsmedizin Rostock /ID# 225436

Rostock, Mecklenburg-Vorpommern, Germany

Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 224835

Berlin, Germany

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 221408

Rome, Lazio, Italy

ASST Spedali civili di Brescia /ID# 224962

Brescia, Italy

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 224071

Meldola, Italy

Shonan Kamakura General Hospital /ID# 224315

Kamakura-shi, Kanagawa, Japan

Kindai University Hospital /ID# 213241

Osakasayama-shi, Osaka, Japan

Osaka University Hospital /ID# 213235

Suita-shi, Osaka, Japan

Juntendo University Hospital /ID# 213255

Bunkyo-ku, Tokyo, Japan

University of Yamanashi Hospital /ID# 229279

Chuo-shi, Yamanashi, Japan

University Clinical Center Serbia /ID# 240674

Belgrade, Beograd, Serbia

Hospital Duran i Reynals /ID# 224007

L'Hospitalet de Llobregat, Barcelona, Spain

Clinica Universidad de Navarra - Pamplona /ID# 224839

Pamplona, Navarre, Spain

CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 226041

Madrid, Spain

Duplicate_Karolinska University Hospital /ID# 239992

Stockholm, Stockholm County, Sweden

Linkoping University Hospital /ID# 239995

Linköping, Sweden

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215631

Kaohsiung City, Taiwan

China Medical University Hospital /ID# 215634

Taichung, Taiwan

Dokuz Eylul University Medical Faculty /ID# 239952

Izmir, Turkey (Türkiye)

Gloucestershire Hospitals NHS Foundation Trust /ID# 241189

Cheltenham, Gloucestershire, United Kingdom